Webinar: Be Prepared and Know the FDA’s Expectations Regarding Immunogenicity Testing – Lessons Learned

The FDA released an update to the Draft Guidance for Assay Development & Validation for Immunogenicity Testing of Therapeutic Proteins in April 2016. This on-demand webinar outlines how the April 2016 draft document is being used in FDA inspections and the FDA expectations for immunogenicity testing. Specific testing parameters and acceptance criteria will be discussed in depth in addition to 483 issued in the field of immunogenicity and what they mean.

What you will learn:

  • How the Draft Guidance for Assay Development & Validation for Immunogenicity Testing of Therapeutic Proteins is being implemented
  • Expectations by the FDA for immunogenicity testing and interpretation in the draft guidance
  • 483 Observations recently issued and what they mean

Our Expert: George Hristopoulos, Scientific Director, Immunoassay

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